Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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The Complex Anatomy Of An ADC Tech Transfer

Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

GUEST COLUMNISTS

A Much-Improved Approach For Understanding And Managing Safety Risks
Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.
CSV Assumes The AI System Sits Still — It Doesn't.
The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.
July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.
In Bioprocessing, Trusted Data Is A Process Variable
As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.
Combination Cell Therapy's Clinical Success Hinges On Manufacturability
Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.
Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
June 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.

PHARMA OUTSOURCING WHITE PAPERS

Spray Dried Dispersions In Controlled Release Formulations
Integrating spray dried dispersions with CR strategies addresses poor drug solubility and the need for tailored release kinetics. Explore considerations to ensure stability and sustained supersaturation.

Accelerating Drug Development: Solid State Chemistry And Strategic Outsourcing
Discover how phase‑appropriate solid‑state chemistry and strategic outsourcing reduce risk, speed development timelines, and enable confident solid‑form selection for complex small‑molecule programs.
The Effect Of Conventional Cooling Versus Controlled Ice Nucleation On Primary Drying Time
See how controlled ice nucleation shortens lyophilization cycles, supports higher drying temperatures, and reduces complexity for amorphous and mixed formulations without sacrificing quality.
Process Analytical Technology In The ADC Bioconjugation Process
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.
The Importance Of Polymorph Screenings
Discover how systematic polymorph screening reduces development risk, safeguards product performance, and enables confident solid‑form selection across the drug development lifecycle.
Practical Considerations For Your Process Characterization Study
Outsourced process characterization can save time, but only with the right preparation. Clear expectations around materials and data interpretation help reduce rework and strengthen confidence.